A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- QUID (Questionnaire for Urinary Incontinence Diagnosis)
研究概览
简要总结
The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health benefits that may be concomitantly achieved from this treatment.
详细描述
This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA. Participants meeting inclusion and exclusion criteria will receive one treatment cycle of active treatment or sham. The device will be equipped with 3 protocols in addition to the standard protocol, two of which are identical to the standard protocol (for active treatment) and one of which does not deliver HIFEM (for sham treatment). The active treatment arm consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12 week follow up visit, and subjects assigned to the sham arm will be crossed over to active treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow up visits. Once unblinded the subject will be treated with the standard protocol of the device.
After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Three blinded protocols available on the device, so care provider will not know to which treatment subject is randomized. Active treatment is not blinded for use in open label portion of study.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
- •Subject is female;
- •Subject is aged 21-80 years;
- •Subject has a body mass index (BMI) < 37 kg/m2;
- •Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
- •Subject is currently sexually active and willing to continue sexual activity throughout the study;
- •Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
- •Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
- •Subject agrees to comply with the study procedures and visits.
排除标准
- •Subject has used the BTL EMSELLA device previously;
- •Subject has any significant pelvic organ prolapse;
- •Subject has clinically significant findings on physical examination;
- •Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- •Subject is unwilling to maintain current level of exercise throughout the study;
- •Subject has been diagnosed with overactive bladder or interstitial cystitis;
- •Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
- •Subject experiences pain with sexual activity
- •Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
- •Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)
- •Subject planning to have surgery during the study;
- •Subject has untreated malignancy;
- •Subject is pregnant, planning to get pregnant or within 3 months postpartum;
- •Subject has a pacemaker;
- •Subject has and implant or IUD containing metal (e.g. copper 7);
- •Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
- •Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week;
- •Subject has received an investigational drug within 30 days prior to signing consent;
- •Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
结局指标
主要结局
QUID (Questionnaire for Urinary Incontinence Diagnosis)
时间窗: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to 18 weeks for active arm; up to 32 weeks for sham arm
Serious adverse events and adverse events related to device will be collected to assess safety
次要结局
- ISCI (Interstitial Cystitis Symptoms Index )/ICPI (Interstitial Cystitis Problem Index)(At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks)
- FSFI (Female Sexual Function Index) Orgasm Domain(At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks)
- FSFI (Female Sexual Function Index)(At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks)
- FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)(At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks)
- Modified Oxford Scale measuring pelvic floor strength(At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks)